Torrent Pharma Inc recalls Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetam
Recalled June 19, 2019 · FDA recall D-1348-2019 · Torrent Pharma
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
2,646,228 bottles
Sold at
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Description
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Manufacturer(s)
Torrent Pharma Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →